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The Long and Winding Road - Shortcuts to FDA Market Authorization

by Mark Swanson and Steve Gompertz, QRx Partners

While most medical devices are required to follow the 510(k) and PMA pathways, the FDA is not oblivious to the ability of some new devices to make considerable improvements to patients’ quality of life. With this in mind, the FDA offers two alternate pathways: Breakthrough Device recognition and the Safer Technologies Program (STeP).

The Breakthrough Device Program is intended for devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, including some combination devices. While these devices still have to go through the applicable 510(k) or PMA process, they get prioritized attention from the FDA.

As the name would imply, STeP is intended for devices, again including some combination devices, that would likely significantly improve the safety of currently available treatments or diagnostics. In these cases, the focus is on devices that address non-life-threatening or reasonably reversible diseases and conditions.

Together, these programs provide an accelerated pathway for a broad range of devices. Both are initiated through the FDA’s Q-Submission, or Q-Sub, program. A guidance document is available from the FDA website, but the process begins with submitting a request. The website also has pages specific to the Breakthrough and STeP programs with guidance on when, how, and what to include in a Q-Sub request.

The FDA also provides guidance documents for both programs, including examples of what to include in a request. The Manufacturer needs to tell a very good “story” explaining what the device is, what it will do, how it meets the program requirements, and why it’s needed on the market sooner rather than later. Through these programs, the FDA will try to respond with questions, if any, within 30 days and make a decision within 60 days.

Since its inception in 2015, the Breakthrough program (including a predecessor program) has granted designation to 728 devices. Of those, 56 have completed the 510(k) or PMA process. While it’s not clear why the others haven’t completed the market authorization process (company folded, insufficient funding, technology challenges, still in progress, etc.), it is clear that this program has helped 56 devices get to market faster and, therefore with less cost, than standard pathways.

If you need help determining if your device might be eligible for one of these programs, creating a successful submission, or responding to FDA follow-on questions, QRx Partners can help. Contact us at or 833-779-7278.

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